by ACRE Aps
DK-MF-000010025 · Denmark · Copenhagen
by ACRE Aps is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 36 |
|---|
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BY ACRE APS (DK) · FDA 3015781799 |
| Devices in EUDAMED | 36 |
| Country of registration | Denmark |